Alternating Compression Pelvic Trauma Binder

ABSTRACT

The present disclosure is generally directed to systems, devices, and methods for compressing the pelvis with alternating pressurized/depressurized air/fluid chambers by encircling the hip region of the patient. In some examples, a device may be applied to a person with a traumatic pelvic injury. A main body may include a strong flexible material such as neoprene and may have the general shape of a wide belt or pelvic girdle. The interior or exterior aspect of the binder may be composed of one or many straps that extend from one end of the binder and are looped through buckles on the other end of the binder and may therefore allow for tightening of the binder upon itself for compression. The end of the strap may contain a fastening device to affix the end of the strap to itself after the strap has been looped through the buckle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application to U.S. application Ser. No. 14/710,527, filed May 12, 2015, which claims priority to and the benefit of U.S. Provisional Application No. 61/991,932, entitled “ALTERNATING COMPRESSION PELVIC TRAUMA BINDER,” filed on May 12, 2014, the disclosures of which are incorporated herein by reference.

TECHNICAL FIELD

The disclosure is generally directed to a medical device and methods used for the compression of a human pelvis.

BACKGROUND

Compressive binder devices for severely traumatized pelvic injuries are a well-known treatment in the medical arts. Severe pelvic ring injuries can damage venous and arterial vasculature as well as pelvic and abdominal viscera. Pelvic ring injuries have been shown to have an associated mortality rate of between 10%-50% depending on the severity of the energy imparted to the pelvis. Rapid exsanguination can occur in severe injuries that damage the pelvic vasculature, aggressive management of this hemorrhage with compression has proven to be the optimal initial treatment.

The pelvic binder or sheet is now the standard of care for the initial treatment of most exsanguinating pelvic ring injuries. Some purposes of the binder or sheet are to: 1. Apply a significant amount of constant force to the pelvis in order to reduce the pelvic volume; 2. Splint the bony pelvis to reduce hemorrhage from fractured bone ends and venous disruption; 3. Stabilize and maintain the integrity of the pelvis for future definitive surgical treatment; and/or 4. Reduce pain.

Conventionally, the binder is applied in a uniform manner that applies pressure on the lateral aspects of the greater trochanters of the hips proximal femurs, so as to compress the hips from the lateral aspect medially. The binder must be applied in a uniform manner so as to distribute the compressive force over a wide surface area on the lateral hips. The uneven distribution of this compressive force has led to the development of pressure induced skin and soft tissue breakdown and necrosis. This soft tissue breakdown and necrosis has been shown to significantly increase the morbidity and mortality of the traumatized patient.

Even with uniform application of a pelvic binder or sheet there is still significant compressive force applied to the pelvis. Skin breakdown and necrosis over bony prominences is still a major complication with the long-term use of a properly applied binder or sheet. Many orthopedic surgeons will elect to remove the pelvic binder after 24 hours and surgically apply an external fixator device in its stead to avoid skin breakdown complications

The surgical application of an external fixator device is not without major possible complications as the patient is often in a critical state of health and even minor insults such as anesthesia or mobilization can quickly cause the patient's status to deteriorate. In many cases the patients' health is in such a precarious state that longer term application of the pelvic binder would allow for the stabilization of their overall health status before they go to surgery for either the application of an external fixator or a more definitive surgery.

SUMMARY

In an aspect, a device for compressing a pelvis includes (a) an elongated flexible body having an internal surface and an external surface and opposing first and second ends adapted to be worn about a patient's pelvis; (b) a plurality of chambers operatively coupled to the elongated body, the chambers being at least one of intermittently inflatable and intermittently distensible; and (c) a fastener configured to couple the first and the second end. In a more detailed embodiment, the plurality of chambers extend at least partially from the internal surface of the elongated body. Alternatively, or in addition, the external surface of the elongated body is comprised of a flexible and low friction material. Alternatively, or in addition, the internal surface of the elongated body is comprised of a soft and conforming material. Alternatively, or in addition, a supporting member is located between the external surface of the elongated body and the plurality of chambers. Alternatively, or in addition, the plurality of chambers are shaped as rings, semi-rings, bard and/or geometric cells.

Alternatively, or in addition, a first group of the plurality of chambers is operatively coupled to a first tubing hose such that pressurizing the first tubing hose pressurizes the first group of chambers to which the first tubing hose is attached. In a more detailed embodiment, the first tubing hose is also operatively coupled to a pressurization device, where the pressurization device pressurizes and depressurizes the first tubing hose according to a predetermined pattern. In a more detailed embodiment, a second group of the plurality of chambers is operatively coupled to a second tubing hose such that pressurizing the second tubing hose pressurizes the second group of chambers to which the second tubing hose is attached. In a further detailed embodiment, chambers in the first group of chambers and chambers in the second group of chambers are arranged about the elongated body in an interspersed pattern with respect to each other.

In another aspect, a method for compressing a pelvis includes: (a) donning a compression device about a patient's pelvis, where the compression device includes an elongated flexible body having an internal surface and an external surface and opposing first and second ends adapted to be worn about a patient's pelvis, a plurality of chambers operatively coupled to the elongated body and extending at least partially from the internal surface, where the chambers are inflatable with a gas and/or distensible with a fluid, and a fastener for releasably coupling the first and the second end; and (b) pressurizing and depressurizing the chambers about the patient's pelvis at least in a predetermined timing pattern to provide alternating compression and by the chambers. In a more detailed embodiment, the plurality chambers extend substantially in parallel longitudinally along the flexible body. Alternatively, or in addition, the plurality of chambers are shaped as rings, semi-rings, bars, and/or geometric cells.

Alternatively, or in addition, the plurality chambers are arranged along the flexible body, and the step of pressurizing and depressurizing the chambers about the patient's pelvis at least in a predetermined timing pattern, (a) pressurizes a first set of chambers while simultaneously depressurizing a second set of chambers and then (b) depressurizes the first set of chambers while simultaneously pressurizing the second set, where steps (a) and (b) are repeated according to a predetermined timing cycle.

Alternatively, or in addition, the step of pressurizing and depressurizing the chambers about the patient's pelvis at least in a predetermined timing pattern, (a) pressurizes a first set of chambers distributed along the elongated body while simultaneously depressurizing a second set of chambers interspersed with respect to the first set and then (b) depressurizes the first set of chambers while simultaneously pressurizing the second set, where steps (a) and (b) are repeated according to a predetermined timing cycle.

DESCRIPTION OF DRAWINGS

The foregoing and other features of the present disclosure will become more fully apparent from the attached drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are, therefore, not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings:

FIG. 1 provides an internal, elevational view of an example binder in accordance with at least an embodiment of the present disclosure;

FIG. 2 provides a top view of the exemplary binder of FIG. 1; and

FIG. 3 provides an external, elevational view of the exemplary binder of FIGS. 1 and 2, all arranged in accordance with at least an embodiment of the present disclosure.

DETAILED DESCRIPTION

In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative examples described in the detailed description, drawings, and claims are not meant to be limiting. Other examples may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, may be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of the present disclosure.

As shown in FIGS. 1-3, examples of the present disclosure are directed to a device and methods for using such a device that may be applied, as a means of pelvic compression, to a severely traumatized patient with a pelvic ring injury for prolonged periods of time avoiding the major complication of skin breakdown. Example of the present disclosure may include a binder device 100 having a body 110 composed of material that allows for compression of the bony pelvis. The inner aspect of the body 100 may have inflatable or distensible (with either or both of a gas or a fluid) pressurized compartments 120 arranged in small rings (as shown in FIG. 2) of variable diameters, for example, that can be individually pressurized and/or de-pressurized to variable pressure settings by a pressurization system.

Example pressurization systems may be set to pressurize alternate compartments 120 of the binder device 100 at any one time. The alternate compartments 120 when not pressurized may be deflated and apply no significant pressure to the pelvis. At time intervals (e.g., variable time intervals), the deflated compartments 120 may be pressurized and inflate to the same pressure as the alternating compartments 120 then those alternating compartments 120 may deflate, relieving the pressure on the skin and soft tissue under those compartments 120.

This alternating pressurization system may allow for the skin and soft tissue that is being directly compressed by the pressurized compartments 120 of the binder device 100 to have a set time of depressurization while its adjacent compartments 120 are pressurized and maintaining the compressive force on the bony pelvis. This process may allow for blood flow to the soft tissues and skin for a set period of time before the alternate compartments 120 are compressed again and that compartment 120 becomes pressurized. This process allows the binder to maintain the compression needed to inhibit intra pelvic bleeding while maintaining the necessary blood flow to the skin and soft tissues in order to inhibit the major complication of skin breakdown and necrosis.

The present disclosure is generally directed to systems, devices, and methods for compressing the pelvis with alternating compressive air or fluid compartments 120 by encircling the hip region of the patient. In some examples, a device 100 may be applied to a person with a traumatic pelvic injury. A main body portion 110 may be composed of a strong flexible material such as neoprene and may have the general shape of a wide belt or pelvic girdle. The interior or exterior aspect 115 of the binder 100 may be composed of one or many strap apparatuses (or strap) 130 that extend from one end of the binder 100 and are looped through buckles 140 on the other end of the binder and may therefore allow for tightening of the binder 100 upon itself for compression. The end of the strap 130 may contain a fastening device 150 to affix the end of the strap 130 to itself after the strap 130 has been looped through the buckle 140. The strap 130 may have many fastener receptacles 160 on its proximal aspect allowing for different mating sites for the fastening device 150. In some examples, the fastening receptacles 160 may be evenly spaced. The fastening receptacles 160 may be placed at variable increments. These different mating sites allow for adjustable tensioning forces to be applied to the pelvis. It is within the scope of the current disclosure to utilize any appropriate fastener 150 as may be known to those of ordinary skill such as, for example: buckles, belts, ties, hook and loop (such as Velcro®) and the like.

The main body 110 of the binder 100 may be composed of a flexible yet non-stretchable material such as neoprene that allows for a conforming fit to the individual patient yet does not allow for stretching of the material and subsequent loss of compression over time. The exterior aspect 115 of the binder 100, excluding the strap apparatus 130, may be covered with a low friction material so as to allow for easy maneuverability of the patient while in the supine position. The inner aspect of the binder 100 may be covered with a soft cushioning material that allows for even distribution of forces to the patient's body's surface area.

The inner aspect of the main body 110 of the binder 100 may house multiple inflatable or distensible air/fluid chambers 120 that may be of variable diameters when fully inflated. These chambers 120 may be arranged in multiple different orientations including horizontal, vertical, or at an angle to the main body 110. Additionally, these chambers 120 may be in the form of rings, semi-rings, bars, geometric cells (for example, and without limitation, circular, square, triangular or hexagonal cells) oriented in a uniform (or non-uniform) arrangement along a portion of the main body 110 of the binder 100. The chambers 120 may be constructed such that when fully inflated/distended they may cause pressure upon the patients' hips and subsequent cause pelvic compression. The chambers 120, when deflated, may put lesser or no pressure on the hips if the alternating chamber 120 is inflated/distended and causing compression. In some examples, the chambers 120 may be inflated/distended in an alternating pattern so that every other chamber 120 at any one time may be inflated and causing pressure on the pelvis.

The chambers 120 may be made of an airtight and/or fluid-tight material that is housed directly next to the inner body material. This may allow for the chambers 120 to exert pressure on the hips while not exposing the skin to an abrasive surface area. The cushioning aspect of the inner body material may shield the body from abrasion and ulceration over time while still allowing for pelvic compression. Each chamber 120 of the binder 100 may have a pressurization hose(s) 170 coupled to the chamber 120 and coupling the chamber 120 to the external environment. For example, if the chamber 120 is an air-filled chamber, the pressurization hose(s) 170 may be connected to an air pump with appropriate valve configurations (as would be readily apparent to those of ordinary skill) to allow the chamber to be inflated/deflated as discussed herein. Likewise, if the chamber 120 is a fluid-filled chamber, the pressurization hose(s) 170 may be connected to a hydraulic pump with appropriate valve configurations (as would be readily apparent to those of ordinary skill) to allow the chamber to be distended/emptied with fluid as discussed herein. In some examples, the hoses 170 from the multiple chambers 120 may all exit the binder 100 at one location. Additionally, groups of chambers 120 may be grouped together, through a manifold for example, to a single hose 170 so that such chamber groups may be inflated/distended simultaneously using a single hose 170, for example.

In some examples, the pressurization and depressurization of the binders' chambers 120 may be controlled by an external pressurization controller that may be programmed to control the connected pumps and valves (pressurization device) to inflate/distend the individual chambers 120 or chamber groups at set or pre-determined time periods and/or patterns. The binders' hoses 170 may be of variable lengths and may be coupled to the pressurization device. The pressurization device may be used to set differing levels of compression pressure to the hips.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims. 

What is claimed is:
 1. A device for compressing a pelvis, comprising: an elongated flexible body having an internal surface and an external surface and opposing first and second ends adapted to be worn about a patient's pelvis; a plurality of chambers operatively coupled to the elongated body, the chambers being at least one of intermittently inflatable and intermittently distensible; and a fastener configured to couple the first and the second end.
 2. The device of claim 1, wherein the plurality of chambers extend at least partially from the internal surface of the elongated body.
 3. The device of claim 1, wherein the external surface of the elongated body is comprised of a flexible and low friction material.
 4. The device of claim 1, wherein the internal surface of the elongated body is comprised of a soft and conforming material.
 5. The device of claim 1, wherein a supporting member is located between the external surface of the elongated body and the plurality of chambers.
 6. The device of claim 1, wherein a first group of one or more of the plurality of chambers is operatively coupled to a first tubing hose such that pressurizing the first tubing hose pressurizes the first group of chambers to which the first tubing hose is attached.
 7. The device of claim 6, wherein the first tubing hose is also operatively coupled to a pressurization device, the pressurization device pressurizing and depressurizing the first tubing hose according to a predetermined pattern.
 8. The device of claim 7, wherein the pressurization device pressurizes the first tubing hose to a different pressure than a second tubing hose operatively coupled to a second group of one or more of the plurality of chambers.
 9. The device of claim 7, wherein a second group of one or more of the plurality of chambers is operatively coupled to a second tubing hose such that pressurizing the second tubing hose pressurizes the second group of chambers to which the second tubing hose is attached.
 10. The device of claim 9, wherein chambers in the first group of chambers and chambers in the second group of chambers are arranged about the elongated body in an interspersed pattern with respect to each other.
 11. The device of claim 1, wherein the plurality of chambers have a shape taken from a group consisting of rings, semi-rings, bars, and geometric cells.
 12. A method for compressing a pelvis comprising: donning a compression device about a patient's pelvis, the compression device including an elongated flexible body having an internal surface and an external surface and opposing first and second ends adapted to be worn about a patient's pelvis, a plurality of chambers operatively coupled to the elongated body and extending at least partially from the internal surface, the chambers being at least one of inflatable with a gas and distensible with a fluid, and a fastener for releasably coupling the first and the second end; and pressurizing and depressurizing the chambers about the patient's pelvis at least in a predetermined timing pattern to provide alternating compression and by the chambers.
 13. The method of claim 12, wherein the plurality chambers extend substantially in parallel longitudinally along the flexible body.
 14. The method of claim 12, wherein the plurality chambers are arranged along the flexible body; the step of pressurizing and depressurizing the chambers about the patient's pelvis at least in a predetermined timing pattern, (a) pressurizes a first set of chambers while simultaneously depressurizing a second set of chambers and then (b) depressurizes the first set of chambers while simultaneously pressurizing the second set, wherein steps (a) and (b) are repeated according to a predetermined timing cycle.
 15. The method of claim 12, wherein the step of pressurizing and depressurizing the chambers about the patient's pelvis at least in a predetermined timing pattern, (a) pressurizes a first set of chambers distributed along the elongated body while simultaneously depressurizing a second set of chambers interspersed with respect to the first set and then (b) depressurizes the first set of chambers while simultaneously pressurizing the second set, wherein steps (a) and (b) are repeated according to a predetermined timing cycle.
 16. The method of claim 12, wherein the plurality of chambers have a shape taken from a group consisting of rings, semi-rings, bars, and geometric cells. 